This constitutes the first Emergency Use Authorization (EUA) following a worldwide Phase 3 trial of a vaccine to help fight the pandemic.
US giant, Pfizer, and Germany’s BioNTech said they are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals.
The distribution of the COVID-19 vaccine in the UK will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunization (JCVI).
In July 2020, Pfizer and BioNTech announced an agreement with the UK to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorized for emergency use. That agreement was increased to 40 million doses in early October.
The companies said they will take immediate action to begin the delivery of vaccine doses to the UK, with the first expected to arrive in the UK in the coming days.
Delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts, they added.
The MHRA’s decision [announced December 2] is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.
Approval awaited in other markets
The vaccine partners have also filed a request for EUA with the US Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.
Earlier this month, the EU agreed a deal with Pfizer and BioNTech for up to 300 million doses of the vaccine.
Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.
Pfizer and BioNTech say they are leveraging their leading vaccine manufacturing and distribution capabilities to quickly scale, manufacture and distribute large quantities of the vaccine at high quality.
Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech said it is able to produce mRNA for commercial supply after having already produced the vaccine candidate doses for the clinical trials. BioNTech is to increase its manufacturing capacity in 2021, once a third site in Germany will start manufacturing to provide further capacities for a global supply of the potential vaccine.
Critical to distribution in the UK will be Pfizer’s manufacturing site in Puurs, Belgium, one of Pfizer’s largest sterile injectable sites. The Puurs site is being used primarily for European supply but will also serve as back up supply to Kalamazoo, Michigan, for the US market.
While the vaccine requires ultra-cold storage and distribution conditions (at around -70°C), Pfizer said its distribution is built on a flexible just-in-time system that can ship the frozen vials quickly to designated points of vaccination at the time of need. “So, this will minimize the need for long term storage anywhere. Vaccination in a pandemic situation is expected to be rapid, with high demand, and we do not expect that the product will need to be stored at any location for more than 30 days.”
The UK government said it was “confident that the cold supply chain needed to distribute the Pfizer/BioNTech vaccine will not cause any problems and will make no difference to the speed at which the UK will receive its doses.”
Pfizer has developed packaging and storage innovations for the vaccine and has specifically designed, temperature controlled thermal shippers that use dry ice to maintain the required conditions. Thermal sensors will be present in every shipper to track conditions. The shippers can also be used as temporary storage units for 15 days by refilling with dry ice.
“When the vaccine is stored in a fridge, it has an effective life of up to five days at temperatures of 2 to 8 degrees, which allows it to be easily stored at distribution centers across the country,” notes the UK Government.
The UK’s JCVI has been advising the government on vaccine schedules: suggesting the vaccine should first be given to care home residents and staff; followed by people over 80 and health and social workers; and then to the rest of the population in order of age and risk. There are no plans for a COVID-19 vaccine to be compulsory.
Vaccination will be managed by the health services in each nation: NHS England and NHS Improvement, NHS Wales, NHS Scotland, and Health and Social Care Northern Ireland.
'A challenging roll-out'
Dr Adam Barker, healthcare analyst, Shore Capital, sees this vaccine distribution project as not without obstacles.
"Make no mistake, this is going to be a challenging rollout. Although the NHS is well versed in delivering vaccines (it delivers around 15m flu vaccines per year as an example), the Pfizer/BioNTech candidate has well flagged characteristics that make it more difficult to deliver.
"Aside from the storage issues and the need to recruit people to deliver the vaccines, there will also be other challenges. For example, the IT system will need to work smoothly to track who has been vaccinated and to notify individuals on when they are required to get the second dose of the candidate (which comes 21 days after the first dose). In addition, Pfizer/BioNTech’s product must be diluted with saline before it is administered, which isn’t very common with other vaccines. Coordinating all necessary support components to deliver the candidate (e.g. syringes, alcohol wipes, gloves) will also have to run smoothly."
Dr Jonas Nilsen, MD and co-founder of travel health and vaccination specialists, Practio, agrees that UK-wide administering of the COVID-19 vaccine poses many logistical challenges.
He said the adoption of a tech-based system could be key to ensuring efficiency in the mammoth task.
"Firstly, utilising an online booking process similar to that of booking a COVID-19 test enables inoculations to be booked at any time, anywhere, enabling the automatic handling of revaccination if people need more than one dose.
"Maintaining and referencing to online patient records, specifically associated with COVID-19 would help those administering the vaccine to improve productivity and improve overall efficiency, providing accurate, up-to date and complete information about patients. This method will create a better foundation for monitoring each patient and who has had what vaccine, especially when concerned with keeping a record of the adverse effects of the vaccinations as time passes.”